FDA: Page 56
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Aerie eyes glaucoma market after early FDA win
Approval of Rhopressa could make Aerie a more attractive takeout option for ophthalmology-focused biopharmas.
By Ned Pagliarulo • Dec. 19, 2017 -
Getty / Edited by Industry Dive
Biopharma scores big win in tax overhaul
Congress passed a tax code rewrite this week. Here's a cheat sheet for what it means for biopharma.
By Lisa LaMotta • Dec. 18, 2017 -
New Year's resolution time: FDA reveals goals for 2018
The regulatory agency looks forward to continued streamlining of regulations and improving access to therapeutics.
By Suzanne Elvidge • Dec. 18, 2017 -
Prescribed Reading: Year-end M&A, Showdown at ASH
New data from the American Society of Hematology conference has the industry buzzing.
By Lisa LaMotta • Dec. 15, 2017 -
Alnylam, Sanofi given the all-clear to resume fitusiran trials
The FDA's decision allows a Phase 2 open-label study and the Phase 3 ATLAS program to re-commence.
By Jacob Bell • Dec. 15, 2017 -
FDA warns Korean OTC manufacturer for GMP violations
A recent warning letter from the regulator flagged labeling concerns and lax quality control on the part of the Seoul-based drugmaker.
By Ned Pagliarulo • Dec. 14, 2017 -
Courtesy of Sanofi
Sanofi's Humalog follow-on gets FDA nod
With its diabetes unit on the decline, Sanofi is banking on a "more affordable" treatment to help prop up revenue.
By Jacob Bell • Dec. 12, 2017 -
Prescribed Reading: Dealmaking begins to pick up as 2018 approaches
It's been a slow year for deals, but it looks like Gilead's buy of Kite could be a catalyst for more M&A.
By Lisa LaMotta • Dec. 8, 2017 -
FDA lays groundwork for regulating 3D-printed drugs
The agency says it's the first regulator in the world to provide technical guidelines for manufacturers seeking to make medical products on 3D printers.
By Jacob Bell • Dec. 7, 2017 -
Novo gains FDA OK for semaglutide
The Danish drugmaker won regulatory approval for its once-weekly GLP-1, strengthening its foothold in the diabetes market.
By Lisa LaMotta • Dec. 6, 2017 -
Amazon pulls pharmacy wholesaler application in Maine
Amazon told regulators last month it does not intend to sell drugs, and the state filings alone would not allow them to do so.
By Shannon Muchmore • Dec. 6, 2017 -
The Brexit countdown continues
With a new home for the EMA now established, the next steps of separating the U.K. from the EU will continue for pharma.
By Suzanne Elvidge • Dec. 4, 2017 -
Mylan wins first US approval of Herceptin biosimilar
Earlier this year, the generics maker reached a settlement with Roche to market the biosimilar, although launch timing in the U.S. remains unclear.
By Ned Pagliarulo • Dec. 4, 2017 -
Senate passes tax bill that repeals individual mandate
Lawmakers will now attempt to work out the differences between the Senate bill and a similar tax bill the House passed last month that preserves the mandate.
By David Lim • Dec. 2, 2017 -
Prescribed Reading: Industry CEOs talk PRVs, IPR, PCSK9
Leschly suggests PRVs should be an alternative source of revenue for biotechs; ear health R&D is all clogged up; and execs agree the IPR process should be thrown out.
By Lisa LaMotta • Dec. 1, 2017 -
Sanofi to propose limits on use of dengue vaccine after safety signal
Recently analyzed clinical data showed the shot could intensify subsequent cases of the disease for individuals who had not previously been infected.
By Ned Pagliarulo • Nov. 30, 2017 -
FDA knocks generic maker for misbranding sleep aid
The warning letter to Magna Pharmaceuticals is only the third such notice issued this year by the FDA office in charge of regulating prescription drug promotion.
By Ned Pagliarulo • Nov. 29, 2017 -
Elizabeth Regan/BioPharma Dive
Catalyst eyes 2018 filing for rare disease drug candidate
Positive data from a second Phase 3 study has Catalyst on track to resubmit Firdapse for potential U.S. approval.
By Suzanne Elvidge • Nov. 28, 2017 -
BioMarin sells latest PRV for $125M
The biotech monetized its coveted priority review voucher, boosting its finances.
By Lisa LaMotta • Nov. 27, 2017 -
FDA pushes for more abuse-deterrent opioid generics
Under new Commissioner Gottlieb, the FDA has been looking to increase competition across markets by ushering more drugs through the system more efficiently.
By Jacob Bell • Nov. 21, 2017 -
EMA lands new home in Amsterdam
The European drugs regulator will leave London to take up residence in Amsterdam after the U.K.'s Brexit vote forced a relocation.
By Lisa LaMotta • Nov. 20, 2017 -
New FDA framework points to boost for cell and gene therapies
The framework may act as a bonus for the industry by speeding development of cell and gene therapies while improving safety and efficacy.
By Suzanne Elvidge • Nov. 20, 2017 -
Elizabeth Regan/BioPharma Dive
Proposed Medicare policy could shift drug rebates to consumers
Currently, rebates and discounts for Part D drugs are "rarely" passed on directly to consumers, although they can lower overall premiums.
By Ned Pagliarulo • Nov. 17, 2017 -
Prescribed Reading: FDA on approval streak, I/O shines
The regulatory agency granted seven approvals this week, including the first pill with a digital sensor, as well as the go-ahead for a new hemophilia drug.
By Lisa LaMotta • Nov. 17, 2017 -
Ultragenyx wins first drug approval, valuable PRV
The FDA OK'd Mepsevii for a rare genetic disease sometimes known as Sly syndrome. But the priority review voucher UltraGenyx received in the process might end up being just as valuable.
By Lisa LaMotta • Nov. 16, 2017
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